Recall Z-1324-2021— Nuvasive Specialized Orthopedics Inc

Name: FDA recall Z-1324-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-12

Class II · Ongoing

Class II FDA medical device recall by Nuvasive Specialized Orthopedics Inc, initiated 2021-02-12. It names 2 FDA 510(k) clearances: K201567, K182170. Product: Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.. Reason: Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments..

Recalling firm: Nuvasive Specialized Orthopedics Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-02-12
Firm location: Aliso Viejo, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K201567 — Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc.·cleared 2020-08-10
K182170 — PRECICE® BONE TRANSPORT SystemNuvasive Specialized Orthopedics, Inc.·cleared 2019-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

Reason for recall

Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

Data sourced from openFDA. This site is unofficial and independent of the FDA.